Deadly effect of experimental treatment and rules of research conduct

The Washington Post and the WSJ Health Blog comment on the deadly effect of an experimental treatment for arthritis and the breach of guidelines for clinical trials:

"Two fundamental rules of clinical research were violated that day, experts said.

First, (the informed) consent forms are to be taken home and considered, not signed on first sight.

Second, when a patient's own doctor is a principal investigator in a study, someone else is supposed to make the proposal."

Update 11/26/2007:
The following investigation found no evidence the experimental drug caused the death of the patient described above and the clinical trial is set to resume.

References:
Death Points to Risks in Research. Washington Post, 08/2007.
Hope Trumped Skepticism as Patient Mulled Study Risk. WSJ Health Blog, 08/2007.
Gene Therapy Study to Resume After Patient Death. WSJ Health Blog, 11/2007.
Image source: OpenClipArt.org, public domain.

Related:


Informed Consent. Family Medicine Notes, 03/2008.

Updated: 03/31/2008

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